RandOmized Study Exploring the Combination of radioTherapy With Two Types of Acupuncture Treatment: The ROSETTA Trial
ROSETTA
1 other identifier
interventional
74
0 countries
N/A
Brief Summary
The ROSETTA-trial will evaluate the effect of acupuncture as a complementary treatment parallel to radiation therapy in oncological patients. The trial is designed as a two-armed trial. Depending on the treatment study arm either verum- or Sham sham-acupuncture will be applied. Acupuncture is applied treatment bi-weekly during the first week of radiotherapy, thereafter weekly until the end of radiotherapy; the follow-up visits include clinical workup as well as questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 cancer
Started Feb 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFebruary 4, 2016
February 1, 2016
2 years
December 8, 2015
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Life
questionnaire
6 weeks after completion of radiotherapy
Secondary Outcomes (1)
Fatigue
6 weeks after radiotherapy
Study Arms (2)
Group A: Verum Acupuncture
EXPERIMENTALGroup A: Verum Acupuncture (Needle Acupuncture) Needlepoints Bilateral PC 6, S 36, L 8, L 9 Unilateral R4, R 6 Acupuncture will be applied for approx. 20 min. with 10 needlepoints. Standard radiotherapy
Group B: Sham Acupuncture
SHAM COMPARATORGroup B: Sham Acupuncture (Needle Acupuncture) Needlepoints 8 needles in the medioaxillary line below the 6th rib, bilateral 2 needles unilateral Sham-acupuncture will be applied for approx. 20 min. with 10 needlepoints. Standard radiotherapy
Interventions
Radiation as indicated by the cancer diagnosis
Needle Acupuncture according to Traditional Chinese Medicine (TCM)
Eligibility Criteria
You may qualify if:
- Patients meeting all of the following criteria will be considered for admission to the trial:
- treatment with radiotherapy
- age ≥ 18 years of age
- Ability ability of subject to understand character and individual consequences of the clinical trial
- written informed consent (must be available before enrolment in the trial)
You may not qualify if:
- Patients presenting with any of the following criteria will not be included in the trial:
- any contraindication to acupuncture
- known coagulopathy or anticoagulation therapy with bleeding time \> 4 minutes, thrombocyte count \< 50 000/μl
- missing compliance
- skin disease in the region of the acupuncture points
- refusal of the patients to take part in the study
- participation in another clinical study or observation period of competing trials,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Asadpour R, Kessel KA, Bruckner T, Sertel S, Combs SE. Randomized study exploring the combination of radiotherapy with two types of acupuncture treatment (ROSETTA): study protocol for a randomized controlled trial. Trials. 2017 Aug 29;18(1):398. doi: 10.1186/s13063-017-2139-5.
PMID: 28851420DERIVED
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stephanie E Combs, Prof. Dr.
Klinikum rechts der Isar, Radiation Oncology, Professor and Chair
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. med., Professor and Chair, Radiation Oncology
Study Record Dates
First Submitted
December 8, 2015
First Posted
February 4, 2016
Study Start
February 1, 2016
Primary Completion
February 1, 2018
Study Completion
February 1, 2018
Last Updated
February 4, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share